Efficacy and Safety of the Atrial Septal Defect Closure for Patients with Absent or Malaligned Aortic Rim Using a Figulla Flex II Device Flared and Straddling Behind the Aorta

Abstract

Background: Although transcatheter closure of atrial septal defect (ASD) is safe and effective for patients with sufficient rim, ASD patients with absent and/or malaligned aortic and/or superior rim have higher risks of device embolization and cardiac erosion. We have treated such high-risk patients using a Figulla Flex II (FFII) device shaped flared and straddling behind the aorta because this method would avoid such serious complications. However, its long-term efficacy and safety remain unclear. Therefore, the midterm efficacy and safety of this method were studied. Methods: We retrospectively evaluated the outcome of 47 consecutive patients with such rim (age 6–73 years, weight 17–75 kg, 31 females) treated with this method at our hospital between February 2016 and September 2019. To make the flared and straddling shape, we selected a FFII 4–6 mm larger than the balloon sizing diameter by stop-flow technique. We also studied the device shape, the disc pressure to the Valsalva wall and their changes over 6 months by transesophageal echocardiography. Results: All procedures were successful, and leakage disappeared within 1 year. During a mean follow up of 37 ± 12 months, complications included a transient sinus node dysfunction and one I° atrioventricular block within 3 months. Whole device shape changed from bulky to thin: the device waist and thickness significantly decreased by around 1.5 mm and 3.5 mm, respectively (p < 0.05), but the two discs remained flared and straddling behind the aorta over 6 months; therefore, the disc edges seldom pressed the Valsalva wall perpendicularly, even though the inner plane of either disc often slightly pressed the wall. Conclusions: ASD closure using a FFII shaped flared and straddling behind the aorta is probably effective and safe for patients with absent and/or malaligned aortic and/or superior rim although requiring care for conduction disorders.